Kornimate/medical-research-clean huggingface dataset:
bioequivalence study (candesartan 8 mg and amlodipine 5 mg)

Conditions: Hypertension

Summary: the purpose of this study is to compare the safety and pharmacokinetics of ckd-330 (fixed-dose combination of candesartan 8 mg and amlodipine 5 mg) with coadministration of the two separate drugs in healthy male volunteers.


Eligibility criteria:
inclusion criteria: 1. healthy male volunteer in the age between 20 and 45 years old. 2. body weight ≥ 55 kg and body weight in the range of calculated ibw ±20%. 3. subjects without a hereditary problems and chronic disease. 4. subjects whose clinical laboratory test values are inside the accepted normal range. 5. understand the requirements of the study and voluntarily consent to participate in the study. exclusion criteria: 1. previous history or present of clinically significant hepatobiliary, nephrological, neurologic, respiratory, hemato-oncological, endocrine, urogenital, psychiatric, musculoskeletal, immune, otorhinolaryngological, cardiovascular system. 2. history of gastrointestinal disease or gastrointestinal surgery to affect drug absorption. 3. history of clinically significant allergies of amlodipine or candesartan or ccb or arb or aspirin or antibiotic. 4. subjects with galactose intolerance. 5. sbp ≥ 140 mmhg or\< 90 mmhg, dbp ≥ 95 mmhg or \< 60 mmhg, pulse ≥ 100 bpm. 6. ast or alt \> 2\*uln, total bilirubin \> 2\*uln 7. serum creatinine \> uln 8. previous history or present of drug abuse. 9. subjects treated metabolizing enzyme inducers or inhibitors such as barbitals within 1 month prior to the first dosing. 10. subjects treated ethical drug or herbal medicine within 2 weeks, otc or vitamin within 1 week prior to the first dosing. 11. subjects treated ip within 2 months prior to the first dosing. 12. subjects with whole blood donation within 2 months or component blood donation within 1 month or blood transfusion within 1 month prior to the first dosing. 13. alcohol \> 21 units/week or cannot stop drinking. 14. cigarette \> 10 cigarettes/day. 15. subjects with the plan dental treatment(extraction, orthodontic, nerve treatment) or any surgery(plastic surgery, eye surgery - lasik, lasek). 16. not eligible to participate for the study at the discretion of investigator.
increasing preoperative cognitive reserve to prevent postoperative cognitive dysfunction in cardiac surgical patients

Conditions: Postoperative Cognitive Decline; Postoperative Delirium; Postoperative Cognitive Dysfunction

Summary: postoperative delirium (pod) and postoperative cognitive decline (pocd) can be observed after cardiosurgical interventions. taken together, these postoperative neurocognitive dysfunctions contribute to increased morbidity and mortality and higher economic costs. preoperative risk factors of postoperative neurocognitive dysfunctions, such as decreased neuropsychometric performance or decreased cognitive daily activities, can be interpreted as reduced cognitive reserve. the aim of this study is to build up cognitive reserves to protect against the development of pod and pocd through preoperative, home-based, cognitive training.

the planned research project is a monocentric, 2-arm randomized controlled intervention study involving 100 patients undergoing elective cardiac surgery with extracorporeal circulation. patients will be assigned to a training group or control group. the intervention involves a standardized, paper-and-pencil-based cognitive training that will be performed by the patients at home for approximately 40 minutes per day over a preoperative period of 2-3 weeks. the control group will receive neither cognitive training nor a placebo intervention. a detailed assessment of psychological functions will be performed approximately 2-3 weeks before the start of training, at the end of the training, during hospitalization, at discharge from the acute clinic, and 3 months after surgery. the primary objective of this study is to investigate the interventional effect of preoperative cognitive training on the incidence of pod during the stay in the acute clinic, the incidence of pocd at the time of discharge from the acute clinic, and 3 months after surgery. secondary objectives are to determine the training effect on objective cognitive functions before the surgery and subjective cognitive functions, as well as health-related quality of life 3 months after surgery.

Eligibility criteria:
inclusion criteria: * elective cardiac surgery (coronary artery bypass surgery, aortic or mitral valve replacement/reconstruction, or combination surgery) with standardized extracorporeal circulation * a sufficiently good knowledge of german is necessary as cognitive training and neuropsychological tests are language-dependent exclusion criteria: * history of stroke and preexisting psychiatric or neurological disorders that may impair the neuropsychological performance

Keywords: cardiac surgery postoperative cognitive decline postoperative delirium cognitive training cognitive reserve postoperative cognitive dysfunction
routine hysteroscopy in ivf/icsi cycles in patients with primary unexplained infertility

Conditions: Primary Infertility Unspecified; Infertility; Ovarian Hyperstimulation; Pregnancy

Summary: the aim of the present study is to evaluate the impact of hysteroscopy prior to starting the ivf (in vitro fertilisation) cycle on treatment outcome in women with unexplained primary infertility.

proper history, examination and investigations are carried out to diagnose causes of infertility. office hysteroscopy will be performed during the luteal phase of the proceeding menstrual cycle using a rigid hysteroscope. controlled ovarian hyper stimulation-embryo transfer (coh-et) using the standard long protocol of induction used in ain shams university maternity hospitals art (assisted reproductive techniques) unit. biochemical pregnancy will be determined by a positive pregnancy test performed 2 weeks after embryo transfer and clinical pregnancy will be defined by the presence of a gestational sac using transvaginal ultrasound performed 6 weeks after embryo transfer.

Eligibility criteria:
inclusion criteria: * patients undergoing ivf/icsi using the standard long gnrh-a (gonadotropin-releasing hormone-a) protocol. * no evidence of uterine pathology by transvaginal ultrasound and hysterosalpingography during the follicular phase. * patients with unexplained primary infertility. exclusion criteria: * patients undergoing ivf using other protocols of induction. * patients with evidence of uterine pathology by transvaginal ultrasound or hysterosalpingography during the follicular phase. * other causes of infertility rather than unexplained factor. * unexplained poor responders during the pending icsi cycle. * patients with abnormal findings at hysteroscopy.

Keywords: icsi ivf hysteroscopy supervision in-vitro fertilization
building adherence to live with and navigate my cystic fibrosis (cf) experience

Conditions: Cystic Fibrosis

Summary: the investigators research group and others have found that patient-reported adherence to all aspects of the regimen is suboptimal and objective measures suggest even poorer adherence. there is little data, however that identifies and examines the reason for nonadherence in an adult cystic fibrosis (cf) population or identifies effective strategies for improving adherence. the investigators propose to evaluate the relative efficacy of a motivational interviewing-focused intervention (mi) in improving adherence and reducing cf-related morbidity compared to a cf education intervention (cfe; attention control group). specifically, the investigators hypothesize that mi will result in improved regimen adherence and reduced cf morbidity compared to the cfe control group.


Eligibility criteria:
inclusion criteria: * have a doctor confirmed diagnosis of cf * age 16 years old or older * prescribed an inhaled mucolytic, inhaled antibiotic therapy, chronic macrolide therapy and/or hypertonic saline therapy for the previous 12 months. * scheduled for a regular visit at either the pediatric or the adult cf clinic at johns hopkins hospital. exclusion criteria: * burkholderia cepacia complex isolated from the respiratory tract within the past 2 years. * had a lung transplant * participated in na_00008649 a pilot study of motivational interviewing for adults with cf.
brazilian randomized study - impact of mri for breast cancer

Conditions: Breast Cancer

Summary: the aim of this study is to evaluate the ability of mri to select patients for conservative treatment of breast cancer. participants: female, over 18 years with breast cancer, stages i, ii and iii candidates for conservative surgery will be randomly randomized to do mri or not according mammary density.

the aim of this study is to evaluate the ability of mri to select patients for conservative treatment of breast cancer.an accurate assessment of the tumor is essential to select the best therapeutic strategy in the treatment of breast cancer.currently, mammography, ultrasound and clinical examination are the standard techniques to assess the extent and location of the tumor.however, these imaging methods fail to assess the real size in approximately one third of patients eligible to conservative treatment.mri has high sensitivity (95-100%) in the detection of invasive cancers as well as being able to detect hidden tumors, multifocality, multicentricity and cancer in the contralateral breast more often and greater accuracy than mammography or ultrasound.

Eligibility criteria:
inclusion criteria: * female, * over 18 years with breast cancer * clinical stages i, ii and iii candidates for conservative surgery exclusion criteria: * contra-indication for breast mri (ex. metal implant) * claustrophobia * impossibility to stay in the prone position for more than an hour * history of allergic reaction to the paramagnetic contrast * history of chronic kidney disease on dialysis * personal history of breast cancer treated surgically in the last 12 months. * pregnancy or breastfeeding past 6 months

Keywords: breast cancer conservative surgery mri
influence of administration route of testosterone on male fertility

Conditions: Hypogonadism

Summary: exogenously administered testosterone will override the normal negative feedback of endogenous testosterone on the hypothalamus and pituitary. constantly, relatively high and constant testosterone levels will cause a drop in fsh and lh production by the pituitary. since fsh and lh are signalling hormones to the testes, endogenous testosterone production and spermatogenesis will be down-regulated. it is expected that intranasal dosing in the morning will mimic the normal physiological pattern of testosterone production thereby avoiding negative side-effects on spermatogenesis. trans-dermal gels give testosterone levels more or less constant over the day and will very likely have inhibitory effects on spermatogenesis. the main objective of this study is to show that twice daily intranasal dosing does not have, or has a smaller inhibitory effect on spermatogenesis in comparison to transdermal testosterone gels.


Eligibility criteria:
inclusion criteria: * age greater than or equal to 50 years but not older than 80 years of age; * serum testosterone level \<13.8 nmol/l; * sperm concentration \> 40 million/ml; * willing to give written informed consent. exclusion criteria: * testicular diseases or having had any surgical procedures applied to the testes; * history or currently existing serious disease of any type, in particular liver, kidney or heart disease, any form of diabetes mellitus, cancer or psychiatric illness; * current androgen, anabolic steroid or sex hormone treatment or any treatment with such compounds in the previous 6 months; * blood donation within the 12-week period before the initial study dose. * history of, or current nasal disorders (e.g. seasonal or perennial allergic rhinitis, atrophic rhinitis, polyposis, abuse of nasal decongestants, clinically relevant nasal septum deviation, recurrent epistaxis) or sleep apnea; * elevated serum psa levels (\> 4 ng/ml for subjects \>= 50 years of age);

Keywords: hypogonadism spermatogenesis quality of life
study of treatment response on igg4 related disease (igg4rd)

Conditions: Autoimmune Disease

Summary: this is an open-label randomized controlled trial to compare the efficacy of prednisone alone and combination therapy of prednisone and mycophenolate mofetil in igg4rd patients.

patients with igg4-rd will be randomized in two therapeutic groups: prednisone alone and combination therapy with prednisone and mycophenolate mofetil. these patients will be followed in 12 months. treatment response and relapse will be recorded, as well as side effects.

Eligibility criteria:
inclusion criteria: * males and females * aged 18 to 70 years old with informed consent * all patients must meet the following diagnostic criteria of igg4rd (2011): 1. swelling, sclerosing and inflammatory involvement of one or more organ, including sclerosing pancreatitis, sialadenitis (mikulicz disease), sclerosing cholangitis, inflammatory pseudotumors, retroperitoneal or mediastinal fibrosis, interstitial nephritis, hypophysitis, sclerosing dacryoadenitis, inflammatory aortic aneurysm, lymphadenopathy, or other inflammatory conditions; 2. elevated serum igg4 (\>1.35 g/l); 3. histopathologic features of fibrosis and/or lymphocytic and polyclonal plasma cell infiltration (and igg4+ plasma cells on immunohistology when performed). patients fulfill 1)+2)+3) are diagnosed as definite igd4rd, 1)+2): possible igg4rd; 1)+3): probable igg4rd; 4. exclusion of other diseases. exclusion criteria: * patients will not be included if meets any of the following criteria: 1. patients who were diagnosed as other autoimmune diseases; 2. patients who were diagnosed as malignant diseases; 3. pregnant and lactating women； 4. active infection: hiv, hcv, hbv, tb； 5. serious organ function failure, expected life time less than 6 months. 6. presenting with mikulicz disease without other manifestations.

Keywords: igg4 related disease igg4-rd response rate relapse
evaluation of pain levels by quantitative pupillometry during the placement of deep venous catheters in sedated patients in intensive care unit (pupicat)

Conditions: Critical Illness

Summary: pain is common in intensive care and gives rise to multiple consequences that can impact the future of patients. the placement of deep venous catheters are painful gestures of common practice in intensive care. however, some patients are ventilated and sedated and their level of pain is difficult to judge. quantitative pupillometry seems to be a reliable tool for assessing pain in these patients unable to communicate. the method is already common practice in the operating room for this indication and recent studies increasingly validate its use in intensive care. the aim of the study is to validate the different levels of pain that can be assessed by pupillometry within this population during catheterization and to identify any non-responding subgroups (in order to conduct future clinical trials evaluating pain therapies).

three groups of patients will be studied : with aminergic drugs / with curare / without aminergic drugs nor curare. the measurement of pain levels by quantitative pupillometry (npi®-200 pupillometer, neuroptics® usa) will be made in intubated, sedated patients, unable to communicate on their level of pain during the placement of a deep venous catheter. pain will be evaluated before starting the placement of the catheter, at puncture(s), at dilation(s), and during the suture of the catheter. simultaneously, rass and bps scores as well as the patient's vital parameters and the cumulative doses of sedation-analgesia, curare and aminergic drugs will be collected.

Eligibility criteria:
inclusion criteria: * patient aged over 18 hospitalized in intensive care unit * requiring the placement of a deep venous catheter (central venous catheter or dialysis catheter) * sedated, intubated, unable to communicate about pain * no opposition to participation in the study exclusion criteria: * any ophthalmological pathology (lesion of the orbital cavity, edematous soft tissue or with an open lesion) * any intracranial pathology (stroke, subarachnoid hemorrhage, tumour, etc.) * patient post-cardio-respiratory arrest within the first 48 hours * medicines interfering with the pupillary reflex: clonidine dexmedetomidine, droperidol, metoclopramide, nitric oxide, scopolamine, atropine * patient protected within the law * previous participation in the study

Keywords: pupillometry
effectiveness of green color exposure on dental anxiety

Conditions: Anxiety, Dental; Post Operative Pain

Summary: the investigator's aim in this study was to evaluate the preoperative anxiety and the pain felt during the operation due to exposure to green light. for this purpose, the participants will wear green or translucent glasses before the operation. the investigator will evaluate the patient's anxiety change and the pain she/he feels during the procedure.


Eligibility criteria:
inclusion criteria: * asa 1 and asa 2 patient population * not having had a third molar surgery before * volunteer to participate in the study exclusion criteria: * dental phobia * patients who will be treated under general anesthesia * refusing the measurements * not filling the vas
transversus abdominis plane block for pain relieve in children undergoing groin surgery

Conditions: Postoperative Pain; Reaction; Anesthesia

Summary: for surgery in the region of the lower abdominal wall the administration of local anesthetic drugs in the epidural space via the caudal route is the preferentially used technique since several decades. the transversus abdominis plane (tap) block features the advantages of a peripheral nerve blockade. the aim of this study is to evaluate potential differences in the effectiveness of postoperative analgesia and to test the hypotheses that the duration of pain relieve ist prolonged after a tap block when compared with an epidural technique.

caudal block (cb) is the gold standard technique for analgesia in children undergoing surgical interventions in the groin. although the efficacy and the safety of this technique is high, nonetheless, there are several caveats such as unwarranted motor blockade of the lower limbs and disturbances of the bladder function, potentially resulting in delayed demission in the ambulatory setting. the effect of the blockade wears off within 4-5h post-block, making the administration of additional pain medication necessary. peripheral nerve blockades (pnb) are an alternative to cb and have a prolonged duration of the analgesic effect. more recently, an alternative method to block neural structures which innervate lower abdominal wall has been described; the transverse abdominal plane block. the ultrasound guided technique improves the safety of margin. however, although this new technique seems to offer substantial advantages so far only experience from small case series are available. in particular, the tap block has not been compared in a systematic trial with the "gold standard", the caudal block.

Eligibility criteria:
inclusion criteria: * male and female children aged 2 - 8 years * physical status classification system (asa) score i or ii * undergoing surgical interventions in the groin (hernia repair, funiculocele ectomy) exclusion criteria: * hypersensitivity to levobupivacaine

Keywords: measure of postoperative pain children undergoing groin surgery
safety, blood levels, drug interaction and effects of repeated doses of gsk1034702

Conditions: Cognitive Disorders

Summary: gsk1034702 is being developed for improving cognitive impairment in diseases such as alzheimer's disease and schizophrenia. this study will be done in healthy men and women of no child beading potential to investigate repeated doses of the study medicine. the study will investigate the following questions, do repeated doses of the study medicine have any important side effects when taken by mouth? how much of the study medicine gets into the bloodstream, and how quickly does the body get rid of it? does the study medicine affect memory, attention and problem-solving skills? what are the effects when the study medicine and dextromethorphan are taken together.


Eligibility criteria:
inclusion criteria: * male or female of non childbearing potential * generally healthy * body mass index 19 - 29.9 kg/m2 (inclusive), body weight greater than or equal to 50 kg for males and greater than of equal to 45 kg for females * normal laboratory test results exclusion criteria: * abuse of drugs or alcohol * smoker or history of regular use of tobacco- or nicotine-containing products in the past 6 months * ecg abnormality (personal or family history) * psychiatric disorder * asthma or a history of asthma * medical illness

Keywords: drug interaction saftey pharmacokinetics cognition
cytokine-induced transcription in depressed inpatients undergoing psychotherapy

Conditions: Depression

Summary: the goal of this observational study is to measure the levels of cytokine-induced transcription factor activation in a cohort of depressed inpatients undergoing psychotherapy. the study aims to answer the following main questions: * do psychological traits (i.e.: social inhibition, negative affectivity, ...) affect the activation of immunomodulatory transcription factors (stat3, nfkb) in depressed patients? * are subjects with these psychological traits affected differently by psychotherapeutic intervention? study subjects are assessed for their psychological and behavioral traits and receive psychotherapeutic care over several weeks during hospital treatment. peripheral blood mononuclear cells are isolated from the study subjects, and activation of transcription factors is measured by flow cytometry.

study subjects are assessed for their psychological and behavioral traits and receive psychotherapeutic care over several weeks during hospital treatment. peripheral blood mononuclear cells are isolated from the study subjects, and activation of transcription factors is measured by flow cytometry.

Eligibility criteria:
inclusion criteria: * diagnosis of current depression exclusion criteria: * inadequate knowledge of the german language * unable to give informed consent * severe psychiatric comorbidities, such as drug abuse and psychotic diseases * deemed critically unstable by their treating physician